VEGF Gene Transfer for Diabetic Neuropathy

Losordo, Douglas, M.D.60 enrolled

Overview

This gene therapy study is being conducted to evaluate intramuscular gene transfer using VEGF (Vascular Endothelial Growth Factor) in patients with diabetic neuropathy in the legs. This condition causes a decrease in feeling and sensation due to diabetes. VEGF is DNA, or genetic material that is injected into the muscles of the leg. Once in the leg, it has been shown to cause new blood vessels to grow under a variety of conditions.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Neuropathy

Interventions

VEGFBIOLOGICAL

3 sets of injections, at 2 week intervals

VEGFBIOLOGICAL

3 sets of injections, at 2 week intervals

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

Inclusion criteria: To be eligible to enroll and remain in the study, patients must meet the following criteria: * Be at least 21 years old. * Have type I or type II diabetes mellitus and require oral anti-hyperglycemic agents or insulin. * Have peripheral neuropathy related to diabetes. Exclusion criteria Patients are to be excluded from the trial if any of the following conditions are met: * Have a history of cancer (other than non-melanoma skin cancer or in-situ cervical cancer) in the last five years. * Be unable to meet study requirements, including approximately 7-9 out-patient visits over a 12 month period.

Locations (2)

Caritas St. Elizabeth's Medical Center Cardiovascular Research/DVM-4-SMC

Boston, Massachusetts, United States

Columbia University Neuropathy Research Center, Neurological Institute

New York, New York, United States

Outcomes

Primary Outcomes

Safety

Time frame: 6 months

Data from ClinicalTrials.gov

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